Association of Clinical Response Criteria and Disease Activity Levels with Physical Function and HRQoL in Patients with Axial Spondyloarthritis: 52-Week Results from Two Phase 3 Randomized, Placebo-Controlled Studies
Author(s)
Magrey M1, Deodhar A2, Mease PJ3, Navarro-Compán V4, Ramiro S5, de la Loge C6, Fleurinck C6, Taieb V7, Mørup M8, Massow U9, Kay J10
1Case Western Reserve University, Cleveland, OH, USA, 2Oregon Health and Science University, Portland, OR, USA, 3Swedish Medical Center and Providence St. Joseph Health, University of Washington, Seattle, WA, USA, 4La Paz University Hospital, IdiPaz, Madrid, Spain, 5Leiden University Medical Center, Leiden, Netherlands, 6UCB Pharma, Brussels, Belgium, 7UCB Pharma, Colombes, France, 8UCB Pharma, Copenhagen, Denmark, 9UCB Pharma, Monheim, Germany, 10UMass Chan Medical School and UMass Memorial Medical Center, Worcester, MA, USA
Presentation Documents
OBJECTIVES:
To examine how reaching different clinical response criteria and disease activity levels translates into physical function and health-related quality of life (HRQoL) improvements in patients with axial spondyloarthritis (axSpA).METHODS:
This post hoc analysis reports results from phase 3 studies BE MOBILE 1 (NCT03928704; non-radiographic axSpA [nr-axSpA]) and BE MOBILE 2 (NCT03928743; radiographic axSpA [r-axSpA], i.e., ankylosing spondylitis [patients fulfilled both modified New York and ASAS classification criteria]). Patients reaching specified clinical response criteria (ASAS: ASAS20 not reached [<ASAS20], ASAS20 reached but not ASAS40 [ASAS20–<ASAS40], ASAS40 reached [ASAS40]; ASAS partial remission [ASAS-PR]: No, Yes), ASDAS disease activity levels (≥2.1, ≥1.3–<2.1, <1.3), or major improvement (ASDAS-MI: No, Yes) at Week (Wk)52 were pooled regardless of treatment (placebo/bimekizumab 160mg Q4W), by study. Associations between achievement of these criteria/disease activity levels and changes in physical function (BASFI [an ASAS component], SF-36 PCS) and HRQoL (ASQoL, EQ-5D-3L utilities [UK tariff]) were assessed. Observed case data reported.RESULTS:
Achievement of higher ASAS response or lower ASDAS levels was associated with sequentially greater mean improvements from baseline in SF-36 PCS score in nr-axSpA (<ASAS20: 5.1, ASAS20–<ASAS40: 9.5, ASAS40: 14.6; ASDAS≥2.1: 9.6, ASDAS≥1.3–<2.1: 12.2, ASDAS<1.3: 16.3) and r-axSpA patients (5.9, 8.4, 14.6; 8.3, 12.5, 17.1). Patients achieving higher ASAS responses or lower ASDAS levels reported sequentially greater mean reductions from baseline in ASQoL score (reflecting improvement): nr-axSpA (<ASAS20: –2.2, ASAS20–<ASAS40: –4.3, ASAS40: –7.2; ASDAS≥2.1: –4.5, ASDAS≥1.3–<2.1: –6.7, ASDAS<1.3: –7.1); r-axSpA (–2.0, –4.3, –6.9; –4.3, –6.6, –6.7). Similar associations were seen with BASFI and EQ-5D-3L utilities, and for ASAS-PR and ASDAS-MI across physical function and HRQoL measures.CONCLUSIONS:
Patients with axSpA achieving increasingly stringent clinical response criteria and lower disease activity levels at Wk52 reported greater improvements in physical function and HRQoL. Amplitudes of improvement were similar between nr-axSpA and r-axSpA.Conference/Value in Health Info
Value in Health, Volume 26, Issue 6, S2 (June 2023)
Code
PCR68
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas